BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URETEX SUPPORT PP KIT X1

    MDR report key: 3001068 · Received March 1, 2013

    Report

    Report Number
    9615742-2013-00143
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    June 13, 2006
    Report Date
    May 7, 2018
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    OTN
    PMA / PMN Number
    K012949
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BRAND NAME: URETEX SUP URETHRAL SUPPORT SYSTEM, CATALOG # 485013, (B)(6).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE REASON FOR MESH IMPLANTATION WAS SYMPTOMATIC PELVIC ORGAN RELAXATION WITH UTERINE PROLAPSE, CYSTOCELE, ENTEROCELE, LOSS OF SUPPORT OF THE APEX OF THE VAGINAL VAULT AND URODYNAMIC STRESS URINARY INCONTINENCE. THE PROCEDURES PERFORMED WERE EXAM UNDER ANESTHESIA, FOUR PUNCTURE OPEN LAPAROSCOPY, LAPAROSCOPIC LYSIS OF ADHESIONS, LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY WITH PRESERVATION OF OVARIAN FUNCTION AT PATIENT REQUEST, HALBAN CULDOPLASTY FOR CORRECTION OF ENTEROCELE, UTEROSACRAL VAGINAL VAULT SUSPENSION, ANTERIOR COLPORRHAPHY, PLACEMENT OF TENSION-FREE VAGINAL TAPE WITH CYSTOSCOPIC GUIDANCE. PRIOR TO PREPPING THE PATIENT, EXAM UNDER ANESTHESIA FAILED TO REVEAL ANY EVIDENCE OF UNSUSPECTED MASSES. THE COMPLICATIONS POST PLACEMENT WHERE IN (B)(6) 2006 PAIN AND NUMBNESS IN LEGS, PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, BLEEDING, DYSPAREUNIA, AND VAGINAL SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89200 URETEX SUPPORT PP KIT X1 URETEX SUPPORT OTN SOFRADIM PRODUCTION NA SFD00244

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R